The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis

NCT03181724 | Completed Results

• 1 other identifier: 2015P002550
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.

Conditions

Trapeziometacarpal Arthritis

Outcome Measures

Primary Outcomes (1)

• Decision Conflict Scale (DCS)

  This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision. We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  Day 1

Secondary Outcomes (5)

• QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire

  Day 1

• Patient Health Questionnaire-2 (PHQ-2)

  Day 1

• Consultation and Relational Empathy (CARE) Measure

  Day 1

• 11-point Ordinal Satisfaction Scale

  Day 1

• Change in Decision Regret Scale After 6 Weeks and 6 Months

  6 week and 6 month follow up

Study Arms (2)

Decision Aid

ACTIVE COMPARATOR

Cohort that will receive a decision aid.

Behavioral: Decision Aid

No Decision Aid (control)

NO INTERVENTION

One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.

Interventions

Decision Aid BEHAVIORAL

Cohort I will be managed with a decision aid (henceforth "DA"), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them.

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• English-speaking
• Diagnosis of trapeziometacarpal (TMC) arthritis

You may not qualify if:

• Prior surgical intervention for trapeziometacarpal (TMC) arthritis
• Previously accessed or used the online TMC arthritis Decision Aid (DA)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.

  PMID: 24470076 BACKGROUND

• Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG Jr. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care. 2000 Sep;38(9):959-69. doi: 10.1097/00005650-200009000-00009.

  PMID: 10982117 BACKGROUND

• Jayadev C, Khan T, Coulter A, Beard DJ, Price AJ. Patient decision aids in knee replacement surgery. Knee. 2012 Dec;19(6):746-50. doi: 10.1016/j.knee.2012.02.001. Epub 2012 Mar 2.

  PMID: 22386538 BACKGROUND

• Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. BMJ. 2001 Sep 1;323(7311):493-6. doi: 10.1136/bmj.323.7311.493.

  PMID: 11532845 BACKGROUND

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Neal Chen
• Organization: Massachusetts General Hospital

nchen1@mgh.harvard.edu

617-726-4700

Study Officials

• Neal Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 9, 2017
• Study Start: May 13, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 14, 2019
• Results First Posted: January 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)